BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD CLEO INFUSION SET

    MDR report key: 23681908 · Received December 1, 2025

    Report

    Report Number
    3012307300-2025-12995
    Event Type
    Malfunction
    Date Received
    December 1, 2025
    Date of Event
    October 6, 2025
    Report Date
    December 1, 2025
    Manufacturer
    ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V
    Product Code
    FPA
    UDI-DI
    30610586028339
    PMA / PMN Number
    K042172
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H3: NO DEVICE OR DEVICE PHOTO WAS RETURNED FOR INVESTIGATION. DUE TO THIS, NO ROOT CAUSE WAS DETERMINED. THE DEVICE HISTORY REVIEW OF THE REPORTED LOT NUMBER FOUND NO NON-CONFORMITIES DURING THE MANUFACTURING PROCESS. IF THE PRODUCT IS RETURNED, THIS COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PWD CALLED TO REPORT SHE HAD RECEIVED ANOTHER LINE BLOCKED ALARM. CONFIRMED FIVE OCCURRENCES OF THE ALARM THIS AFTERNOON. PWD NOTICED BGS STARTING TO RISE PRIOR TO CHANGING OUT THE LAST SITE. INFUSION SET LOOKED NORMAL; PWD DENIED ANY BENT TUBING. WEARING SITE ON ABDOMEN. PREVIOUS INFUSION SET CANNULA DID NOT APPEAR BENT AS WELL. PWD WAS IN THE PROCESS OF CHANGING OUT THE INFUSION SET AND CASSETTE TO TRY TO RESOLVE THE ISSUE. AFTER CHANGING OUT CASSETTE AND TUBING, PWD RECEIVED ANOTHER LINE BLOCKED ALARM. DISCUSSED WITH PWD TRYING A NEW SITE FOR INFUSION PLACEMENT. PWD AGREED TO USE THE LOWER RIGHT SIDE OF HER BACK. WALKED PWD THROUGH CLEO PLACEMENT SUCCESSFULLY. PWD WAS ABLE TO RESOLVE WITH CURRENT CASSETTE AND FILL CANNULA SUCCESSFULLY TO CLEAR THE ALARM. THE OPERATOR OF THE DEVICE WAS THE LAY USER OR PATIENT. THERE WAS NO PATIENT HARM/ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2266004 CADD CLEO INFUSION SET SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V 7220 4448981 30610586028339

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female